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510(k) K121533

ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET by Tosoh Bioscience, Inc. — Product Code LPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2012
Date Received
May 24, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinary Homocystine (Nonquantitative) Test System
Device Class
Class II
Regulation Number
862.1377
Review Panel
CH
Submission Type

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  • K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (May 7, 2012)
  • K083222 — AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 (July 31, 2009)
  • K080851 — A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY (October 10, 2008)
  • K073640 — ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS (April 24, 2008)
  • K071971 — DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZ (September 17, 2007)
  • K063701 — TECO HOMOCYSTEINE ENZYMATIC ASSAY (April 11, 2007)
  • K063206 — DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CON (December 28, 2006)